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A 2011 study has linked the use of INFUSE bone grafts to a complication that can cause male infertility.

Bone grafting is a surgical procedure in which bone or a synthetic bone-like protein is used to reinforce a broken or weak bone and encourage natural bone growth. INFUSE is a bioengineered bone growth protein used for bone grafts. It is primarily used for spinal fusion surgery, but is also approved for dental surgery and for the treatment of shinbone fractures. INFUSE is routinely as well as number of off-label purposes, including neck surgery and back surgery.

Since its approval in 2002, INFUSE has been associated with an ever-growing list of potential side effects. Most recently, doctors at Stanford University’s School of Medicine linked the use of INFUSE to retrograde ejaculation, a complication that causes sterility in men.

Retrograde ejaculation occurs the bladder doesn’t function correctly and semen is directed into the urinary bladder rather than the urethra. This condition at a significantly higher rate in men who received INFUSE bone grafts when compared to men who received other bone grafts or no bone grafts. Retrograde ejaculation associated with INFUSE bone grafts may be temporary or permanent.

The Stanford study included 243 male patients who underwent lumbar fusion surgery. Sixty-nine patients were treated with INFUSE; 174 received traditional bone grafts. Five of the patients treated with INFUSE developed retrograde ejaculation. Only one of the patients treated with a traditional bone graft developed the complication.

Patients

With retrograde ejaculation

Temporary
condition

Permanent
condition

INFUSE

69

5 (7%)

2 (40%)

3 (60%)

Traditional graft

174

1 (.01%)

1 (100%)

0

All Patients

243

6 (2%)

3 (50%)

3 (50%)

The INFUSE label mentions that retrograde ejaculation may sometimes occur after treatment with INFUSE bone grafts. However, Medtronic, the manufacturer of INFUSE, considers this to be a complication of surgery, not a risk associated with the Medtronic product.

Dr. Eugene Carragee, the lead author of the Stanford study, disagrees. He believes all men who are considering having children should be alerted that infertility is a possible side-effect of INFUSE.

Have you suffered retrograde ejaculation or sterility after treatment with INFUSE Bone Grafts? We urge you to contact the Green Bay pharmaceutical injury lawyers at Hupy and Abraham. You may be eligible to take part in a Wisconsin INFUSE lawsuit. To learn more, contact Hupy and Abraham at 1-800-800-5678.